mHealth

March 28, 2013

Mobile apps have proven to be valuable tools for collecting
ODLS in this last round of Project HealthDesign. While the benefits are clear, however,
creators of mobile apps must contend with a complicated interplay of safety, cost,
usability, and accessibility in order to produce high quality software. Weakening
these foundations can lead to misuse by consumers, or rejection by
practitioners. On the other hand, overabundance of requirements can stall
progress and hinder the utility of these applications.

A few weeks ago, the Healthcare
Information and Management Systems Society (HIMSS) held its 13th
annual conference in New Orleans, LA. In one notable e-session, presenters Katharina
Steininger and David Rückel outlined the values of key stakeholders in mobile
health applications, and thus the priorities that should be used in
applications themselves. A copy of their slideshow is available here.

In “Mobile Health
Applications—Strategic Stakeholders’ Perspectives,” Steininger and Rückel
name key stakeholders in mobile health applications: patients, practitioners in
private practices, emergency medical services and mobile homecare, hospitals
and nursing homes, application developers, and statutory and private health
insurances. While the stakeholders often have common aims such as higher
quality care and improved security, their priorities are unique and often contradictory.

The solution here is specificity: choose your stakeholders,
and this will define your priorities. While the presenters describe
doctor-to-patient and doctor-to-doctor style applications, they leave out the
most relevant setting: patient-to-doctor communication.

Project HealthDesign teams inherently centered themselves
around patients by designing mobile apps to use the data that embodies
specificity: ODLs. By incorporating Observations of Daily Living, developers
automatically look to the values of patients, and so produce a more effective
application. Applications like BreathEasy
even provided a separate dashboard for clinicians, allowing both the smartphone
and computer-based portals to serve the exact needs of targeted users.

A final note on the importance of specificity: On Tuesday,
March 19, the Energy and Commerce Committee hosted a hearing
regarding the regulation of mobile health applications. In view of whether
mobile health applications should be considered medical devices, gray areas indeed
exist in applications that intend to replace monitors already used in the
clinical setting. Applications dedicated to the capture of ODLs, on the other
hand, add entirely unique patient-defined and patient-generated data to the
workflow. The specifically non-clinical nature of ODLS requires a different
framing of the quality question—one that addresses both the reliability from
the patient’s perspective and accountability on the part of the clinicians. If
quality standards are to be applied to this type of mobile app, they will have
to be quite different from the standards currently used for clinical care
metrics: if not necessarily relaxed, they must account for the idiosyncrasies
of data shaped at the level of the individual.

Ingenuity and flexibility are essential to the development
of quality mobile applications. As long as developers remain keyed into the patient
perspective, they should be encouraged to use these faculties as effectively as
possible.

March 14, 2013

I recently presented the BreathEasy
project at the mHealth Summit,
sponsored by HIMSS, as part of a panel on
Pulmonary Disease Management. In addition to BreathEasy, one of the other
panelists presented on asthma – the M-CHESS project at the University of
Wisconsin, Madison. M-CHESS is part of a larger study, The Center for
Health Enhancement Systems Studies (CHESS), with a goal to optimize
individuals' health behaviors, quality of life, and access to services through research
and development of innovative health systems.

Like BreathEasy, M-CHESS was
focused on self-management of asthma in inner-city patients using a smartphone.
M-CHESS recruited 218 teens and randomized them to two groups – experimental,
and control for a study period of 12 months, and then a follow-up of 12 months.
All participants were provided with smartphones; the experimental group also
received access to the M-CHESS interface, featuring an interactive,
Internet-based asthma education program, peer support mechanisms and automated
reminders for asthma control medicines and data collection. Researchers used
the Asthma Control Test (ACT) to measure how well an individual’s asthma
symptoms are being managed. Initial analysis shows a significant effect of
M-CHESS on the change in ACT scores across the first 60 days on study (p=.011).
On average, the M-CHESS group showed a 2% improvement in ACT score per day of
study over the control group. Ongoing analysis will examine whether the drop-off
in improvement of symptom control is related to a decline in use of the M-CHESS
application and attempt to identify specific subgroups for which M-CHESS may
provide the greatest benefit in asthma symptom control.

The two other panelists presented on tuberculosis (TB)
projects. The University of San Diego presented on a project that used mobile
phones for conducting directly observed therapy via video upload (VDOT) in the
US and Mexico. Overall, patients liked using the phone to upload videos, and
the compliance rate with timely uploads was high. VDOT represents an additional
option to resource intensive traditional, in-person DOT.

Researchers from the University of Utah presented on their TextTB
randomized control pilot study which looked at the acceptance and
feasibility of a patient-driven mobile phone intervention to support TB
treatment adherence in Argentina. Patients were asked to text in when they had
taken their medication. Overall, adherence and acceptability of the
intervention was relatively high, but mobile phone feasibility issues such as
lost messages, modem issues, and running out of SMS credits caused some
difficulties for some participants. Further research is needed to evaluate the
potential for this method of reporting once these issues have been addressed.

Overall, the panel was very interesting – with findings from
all participants providing valuable lessons for future work in mobile health
apps. Next, we’ll report on our attendance at the Health IT for the Underserved
Conference.

July 24, 2012

Last July, the U.S. Food and Drug Administration (FDA) issued draft guidance on how the agency intended to regulate certain mobile medical applications (apps). My colleague, Deven McGraw, described the guidance in a post last year. The draft guidance sparked heated debate. And some in Congress recently pushed to delay the FDA’s final adoption of the guidance for fear that it might stifle innovation.

The story of Congress’s brush with the proposed guidance is brief but noteworthy. During a Senate Health, Education, Labor and Pensions Committee hearing in April 2012 on the Food and Drug Administration Safety and Innovation Act, the legislation that authorizes the FDA to collect user fees from the companies it regulates, Senator Michael Bennet (D-CO) proposed an amendment that would have placed a moratorium on the FDA’s publication of the final guidance. “I appreciate very much the work the FDA has done to receive stakeholder input, but this interaction between health information and medical devices must be handled delicately. Technology is evolving and being adopted rapidly. I think Congress must provide the proper due diligence on this issue for our constituents, including a number of startups, small businesses, and patients in my home state,” said Bennet as he described his rationale for the moratorium.

Ultimately, Congress passed the Food and Drug Administration Safety and Innovation Act without the moratorium. As enacted, the Act allows the FDA to move ahead with its plans to regulate mobile medical apps while the U.S. Department of Health and Human Services develops a report on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety and avoids regular duplication.”

Now that the specter of a moratorium is no longer, the FDA is expected to release its final guidance as soon as the end of the year. A brief refresher on the FDA’s regulation of medical devices and on the guidance, as the FDA proposed it in July 2011, is below.

1. Background on the FDA’s Regulation of Medical Devices

A product is a medical device under the federal Food, Drug and Cosmetic Act (the FDCA) if it is “an instrument, apparatus, implement, . . . including any component, part, or accessory, which is . . . [either] intended for use in the diagnosis . . . or . . . cure, mitigation, treatment, or prevention of disease, . . . [or] intended to affect the structure or any function of the body of man . . .” The FDA has stated that for software to fall under this definition, “it is sufficient that it is intended to be used in the process of diagnosis, preventing, or treatment of medical conditions, and it is not necessary that the software actually make or recommend a final diagnosis.” The FDA evaluates intended use by looking at factors surrounding the product’s promotion and distribution.

Vendors of software that qualifies as a medical device must register as manufacturers and list their products with the FDA. The FDA classifies and regulates devices under three categories, according to the amount of potential risk associated with the device’s intended use and indications for use. Class I devices present the lowest risk and are typically exempt from the pre-market submission process, but are subject to general controls required for all devices, including registration, labeling, adverse event reporting, and good manufacturing practices. Class II devices must generally undergo the pre-market notification process. Class III devices are most stringently regulated and require pre-market approval.

2. The FDA’s Draft Guidance on Regulation of Mobile Medical Apps

The FDA’s July 2011 draft guidance document indicated that the Agency intended to apply its regulatory oversight to a subset of mobile apps called “mobile medical apps,” defined as a mobile app that meets the definition of a “device” that either is used as an accessory to a regulated medical device, or transforms a mobile platform into a regulated medical device. The FDA proposed to monitor and apply enforcement discretion to other apps that qualify as devices but do not meet the mobile medical app definition; a manufacturer may choose to register and list, and to seek the FDA approval or clearance for such apps.

The guidance also listed certain apps that the FDA does not consider to be “mobile medical apps,” including “mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.” Examples of health and wellness apps are provided in the guidance, and include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, etc. In contrast, a mobile medical app is one that is intended for “curing, treating, seeking treatment for, mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.”

As Deven pointed out in her post last summer, the FDA tried to draw clear lines and offered more examples of mobile medical apps in the guidance (see appendix A). However, the distinction between mobile medical apps and health/wellness apps is not always clear. Today, medical conditions are significantly improved — and even prevented — by healthy behaviors, and providers might prescribe or at least recommend particular diet or exercise protocols as part of medical treatment. Many mobile health applications in development and in active use today fall in a gray area between medical and health/wellness. Where do you think the consumer-facing health applications that the Project HealthDesign teams are testing fall?

Comments on the FDA’s draft guidance were due by October 19, 2011 and reports indicate that the FDA received no small amount of feedback. We anxiously await the final guidance and will keep everyone posted.

January 10, 2012

Visit KevinMD.com today to read “Using a mobile app to help chronic pain,” an op-ed by Roger Luckmann, M.D., M.P.H. Dr. Luckmann, who is a family physician, served as principal investigator of a past Project HealthDesign team from the University of Massachusetts Medical School. His team designed an electronic pain and activity diary to help patients document their daily pain experiences, medication regimens and physical activities. This system inspired Dr. Luckmann’s work on a similar mobile application that is set to launch in the Mac App Store soon. Read the article to hear Dr. Luckmann’s perspective on effectively managing pain by learning more about patients’ daily lives and activities.

December 01, 2011

From new PHR platforms to creative mobile health applications, the opportunities for improving health and health care seem to multiply daily. We hope to see more developers and designers become passionate innovators in the health and health care space. Participating in developer challenges such as these upcoming opportunities might help you catch the vision!

Robert Wood Johnson Foundation Challenge

Aligning Forces Challenge

The challenge: Develop an application that builds on the publicly available Aligning Forces for Quality (AF4Q) health care quality measures and helps patients access better care.

Requirements and desired functionality: The application should incorporate AF4Q health care quality measures, allow patients easy access to inpatient and outpatient health resources, and guide them through the decision-making process.

The challenge: Develop an application that empowers individuals to improve their heart health.

Requirements and desired functionality: The application should educate individuals about the Million Hearts initiative, allow individuals to input information about their current health state, use the health data they provide to generate targeted recommendations about how to improve their heart health, and be capable of transferring the individual’s information to an EHR using Direct specifications.

July 12, 2011

In the past 10 years, there’s been a huge increase in the use of cell phones (particularly smartphones); social media, including Twitter, Facebook and blogs; networking tools; and information sharing systems, including mobile geolocation applications such as Foursquare. These tools may offer new opportunities for enhancing techniques and processes for collecting health data, including participant recruitment; tracing; maintaining contact with participants in longitudinal studies; cognitive interviewing; and passive data collection.

Text messaging is one of the most popular communication methods in the world. The pervasiveness, low cost and convenience of mobile phones make Short Message Service (SMS) texting an ideal tool for disseminating health information to—as well as gathering health information from—consumers. It’s also a direct and immediate route to reach people; I tend to think of it as the most intimate form of high-tech communication.

Despite these advantages, rigorous evaluations of new technologies in health services research applications have been rare. The few SMS interventions that have been well-studied suggest that text messaging systems can effectively increase medication and appointment adherence and sustain health promotion behaviors such as smoking cessation, diabetes, asthma management and depression.

I’ve been so enamored of texting and its potential over the past couple of years that I decided to build an SMS platform for sending and receiving messages for health behavior change interventions. After reflecting on these trends and considering how we can make the BreathEasy smartphone experience more engaging, we hit on the idea of integrating SMS notifications with the application.

So that’s where we are now: devising and testing methods to tie our SQL back end from the BreathEasy application side to the SMS platform in order to generate three kinds of messages. The first type of tailored reminder prompts participants to complete diary entries and/or provide peak flow readings; the second involves health alerts related to air quality, excessive use of rescue inhalers and peak flow readings; the third type of messages are health promotion messages that address general wellness and smoking cessation.

For BreathEasy, rather than focusing on text messaging as a mode of intervention or primary collection of observations of daily living (ODLs), we decided to try using SMS as an adjunctive technology. Our SMS-adjunct (SMS-a), is intended to support the collection of ODLs; SMS-a provides participants interactive, dynamically tailored compliance reminders via a smartphone application. Beyond serving as a technical and process proof of concept, we intend to evaluate the effect of SMS-a on increasing participant satisfaction, retention and data quality.

We’re eager to get started with ODL collection and even more excited to observe how things go with this integration. We’ll be sure to update you about our experience when we go live.

July 06, 2011

One of the things I love about our project and the other Project Health Design projects is the creative use of cell phones to collect data and share health information. Cell phones have so much potential to expand access to health care for people who, for any number of reasons (e.g., lack of health insurance, distance to a health facility, unsure when it is appropriate to go see a doctor), might have limited access.

I recently learned of an organization operating in the West African country of Mali that uses some of the same methods we use in FitBaby. Like our project, Pesinet is committed to the early detection and prevention of illnesses among babies and young children. The similarities between our projects show the power of mobile technology to improve health for children around the world. The differences highlight the stark contrasts between our problems and needs here in the U.S. and the problems and needs in West Africa.

FitBaby focuses on infants who are highly at risk for long-term chronic illness because they were born pre-term. Pesinet works with infants and young children (up to age five, 20 percent of whom do not live to see their fifth birthdays) in Mali — almost all are high-risk because of the poverty and lack of health care in the country.

Both projects use cell phones to record health information about the children and then transmit the data via the cellular network to a central database, where health care professionals can access the data and review it for concerns. In the FitBaby project, we offer smartphones to parents so that they can record weight, diaper use, fussiness and other ODLs in the convenience of their homes. Parents can use the data to help determine if they should contact a health care provider about their baby’s health. A nurse case manager may also contact parents if she or he is concerned about the baby’s health indicators. Pesinet sends trained health care workers to families’ homes weekly to assess weight, diarrhea, fever, vomiting and cough (learn more). The health care workers use a cell phone to record data, transmit the data to a central health facility and receive feedback about whether the family should take the child in for further medical evaluation.

I find it thrilling that cell phones can be used in similar ways all around the world to serve the health needs of babies and young children. Best wishes to the folks at Pesinet! May your work be successful in improving the health of thousands of babies in Mali!

February 17, 2011

In his recent blog post, “Data, Apps and the Rules that Bind Them,” Steve Downs, assistant vice president of the Robert Wood Johnson Foundation’s Health Group, comments on the popularity of mobile health and the importance of personal health record (PHR) data. In the post, Downs notes several policy questions related to mobile health privacy and security that must be addressed if the mHealth surge is to continue.

“Until policymakers step in and provide guidance, the chilling effect on innovation will continue, furthering our reliance on an antiquated model of care that does little to empower patients to be active participants in their own health decisions.”

He notes three PHR-related themes that are particularly important as policymakers look toward the future of mobile health: separating the apps from the data, expansion of the definition of health information, and the increasingly social nature of health care.